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Future Of TG’s Ukoniq In Question As Drug Attracts Closer FDA Scrutiny

 
• By Alaric DeArment

The agency has suspended enrollment in Ukoniq trials while also hinting at greater scrutiny of “the continued marketing” of the drug.

Pharmacovigilance (PV or PhV), also known as drug safety, is the pharmacological science to detection, monitoring, and prevention of adverse effects with pharmaceutical product. Medical safety concept
TG's Ukoniq has come under increased FDA scrutiny over its safety-efficacy profile • Source: Shutterstock

Safety concerns that led to the US Food and Drug Administration placing a partial clinical hold on some trials of TG Therapeutics, Inc. PI3K-delta inhibitor Ukoniq (umbralisib) are looking potentially more serious as the FDA is now also looking into the overall safety-efficacy profile of Ukoniq for its marketed indications, follicular lymphoma (FL) and marginal zone lymphoma (MZL).

TG had initially disclosed on 27 January that the FDA placed a partial clinical hold on studies of Ukoniq combined with the CD20-targeting monoclonal antibody ublituximab combination, nicknamed U2, due to concerns about an imbalance in deaths between

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